# FDA recall Z-2528-2018

> **Medela Inc** · Class II · device recall initiated 2018-02-07.

## Product

Invia Motion Negative Pressure Wound Therapy System.  Labeled as:      a. Endure Negative Pressure Wound Therapy (Model 087.4010);    b. 15 Days Negative Pressure Wound Therapy (Model 087.4012);    c. 60 Days Negative Pressure Wound Therapy (Model 087.4014);    d. Endure Negative Pressure Wound Therapy (Model 087.4020 );    e. 15 Days Negative Pressure Wound Therapy (Model 087.4022);    f. 60 Days Negative Pressure Wound Therapy (Model 087.4024).      Product Usage:  The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

## Reason for recall

Device may display a battery missing error.

## Distribution

US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX.      Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands.

## Key facts

- **Recall number:** Z-2528-2018
- **Recalling firm:** Medela Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-08-01
- **Termination date:** 2018-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** McHenry, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2018

## Citation

> AI Analytics. FDA recall Z-2528-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2528-2018. Source: US FDA. Licensed CC0.

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